Current Trials

Further information regarding clinical research studies approved by the FDA can be found at ClinicalTrials.gov. For interest in being a healthy subject volunteer please visit Indiana Clinical and Translational Institute or call 317.278.2176.

Indiana University Health Methodist Hospital

Understanding Outcomes With the EMBLEM™ S-ICD in Primary Prevention Patients With Low Ejection Fraction
PI: Deepak Bhakta, MD
Additional study site: Indiana University Health Saxony Hospital

Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
PI: Arthur Coffey, MD
Additional study sites: Indiana Univeristy Health University Hospital and Indiana University Health Melvin and Bren Simon Cancer Center

Zenith® TX2® Low Profile TAA Endovascular Graft Clinical Study
PI: Joel Corvera, MD

Clinical Investigation Plan of the Cook Formula 535 Iliac Balloon-Expandable Stent
PI: Michael Dalsing, MD
Additional study sites: Indiana University Health Ball Memorial, Indiana University Health Bloomington and IU Health Saxony Hospitals

Prospective Observational Study to Compare Performance Characteristics of the Arctic Sun System Versus Wrap Cooling for Therapeutic Hypothermia in Sudden Cardiac Arrest Patients
PI: Tim Ellender, MD

Clinical Study to Evaluate the Safety and Effectiveness of the Zenith® Branch Endovascular Graft-Iliac Bifurcation
PI: Andres Fajardo, MD

Evaluation of Reactivity of Mononuclear Cells to Collagen V in Lung Transplant Patients
PI: Mark Geraci, MD

Donor Smoke Exposure and the Relationship to Primary Graft Dysfunction
PI: Chadi Hage, MD

Extracorporeal Photopheresis for the Management of Progressive Bronchiolitis Obliterans Syndrome in Medicare- Eligible Recipients of Lung Allografts 
PI: Chadi Hage, MD

A Phase 2b, Randomized, Controlled Trial Evaluating GS-5806 in Lung Transplant (LT) Recipients with Respiratory Syncytial Virus (RSV)
PI: Chadi Hage, MD

US-based, observational, drug registry of Opsumit® (macitentan) new users in clinical practice
PI: William Harvey, MD
Additional study site: Indiana University Health North Hospital

A Prospective, Single Arm, Multi-Center Clinical Study in Collaboration with the InterAgency Registry for Mechanically Assisted Circulatory Support (INTERMACS®) to Evaluate the Thoracotomy Implant Technique of the HeartWare HVAD® System in Patients with Advanced Heart Failure
PI: Zubair Hashmi, MD

Pilot Study of Clinical Safety and Feasibility of the PLGA Poly-L-Lysine Scaffold for the Treatment of Complete (AIS A) Traumatic Acute Spinal Cord Injury
PI: Eric Horn, MD

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study To Access The Safety And Efficacy Of ART-123 In Subjects With Severe Sepsis And Coagulopathy
PI: Raj Kapoor, MD

A Phase 3, Multi-center, Randomized, Open-label Study of Carbavance (Meropenem RPX7009) Versus Best Available Therapy in Subjects with Selected Serious Infections Due to Carbapenem-resistant Enterobacteriaceae
PI: Amy Kressel, MD

National Biological Sample and Data Repository for Pulmonary Arterial Hypertension
PI: Tim Lahm, MD
Additional study sites: IU Health North and IU Health University Hospitals and the IU Health Simon Cancer Center

A randomized, double-blind, placebo-controlled, prospective, multicenter, parallel group study to assess the safety and efficacy of macitentan in patients with portopulmonary hypertension
PI: Tim Lahm, MD
Additional study sites: IU Health University Hospital and IU Health Simon Cancer Center

A Multicenter, Randomized, Partial-Blinded, Placebo-Controlled Study to Evaluate the Safety and Efficacy of a Human Plasma-Derived Alpha1-Proteinase Inhibitor in Subjects with New-Onset Type 1 Diabetes Mellitus
PI: Cary Mariash, MD

Medtronic Product Surveillance Registry Base Protocol
PI: Cary Mariash, MD

A Phase 3, Placebo-controlled, Randomized, Double-blind, Multi-center Study of LJPC-501 in Patients with Catecholamine-resistant Hypotension (CRH)
PI: Chris Naum, MD

A Phase III, case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated with dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures
PI: Robert Lawrence Reed II, MD

Phase III, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of AB103 as Compared to Placebo in Patients with Necrotizing Soft Tissue Infections (NSTI)
PI: Robert Lawrence Reed II, MD

A Multinational, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Effect of Ticagrelor 90 mg twice daily on the Incidence of Cardiovascular Death, Myocardial Infarction or Stroke in Patients with Type 2 Diabetes Mellitus
PI: George Revtyak, MD

Protocol for the Collection and Transfer of Cystic Fibrosis Lungs for Research Purposes
PI: David Roe, MD

Placement of AoRTic TraNscathetER Valves Trial II:  The Safety and Effectiveness of the SAPIEN XT™ Transcatheter Heart Valve with NovaFlex and Ascendra delivery systems in Intermediate and High Risk for Aortic Valve Surgery and Patients Who Cannot Undergo Surgery
PI: Anjan Sinha, MD

HeartMate III™ IDE Clinical Study Protocol
PI: I-wen Wang, MD

Prospective, International, Multi-Center, Randomized Clinical Investigation of Transmedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
PI: I-wen Wang, MD

A Prospective, Multicenter, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Macitentan in Patients with Pulmonary Hypertension after Left Ventricular Assisted Device Implantation
PI: I-wen Wang, MD

Syncardia 50cc Temporary Total Artificial Heart (TAH-T) as a Bridge to Transplant (BTT)
PI: I-wen Wang, MD

A Prospective, Randomized, Controlled, Un-blinded, Multi-Center Clinical Trial to Evaluate the HeartWare Ventricular Assist System for Destination Therapy of Advanced Heart Failure
PI: Thomas Wozniak, MD

Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (EVLP) as an Assessment of Extended/Marginal Donor Lungs
PI: Thomas Wozniak, MD

Heartware Post-Approval Study:  A Multi Center, Post-Approval Study Providing Continued Evaluation and Follow-up on Patients Who Received a HeartWare® Ventricular Assist System During IDE Trials for the Treatment of Advanced Heart Failure
PI: Thomas Wozniak, MD

A Prospective, Randomized, Controlled, Unblinded, Multi-Center Clinical Trial to Evaluate the HeartWare® Ventricular Assist Device System for Destination Therapy of Advanced Heart Failure
PI: Thomas Wozniak, MD

IU Health North Hospital

A U.S. Post-Approval Study of the PROMUS Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System
PI: Mark Fisch, MD

A multicenter, double-blind, randomized, placebo-controlled, Phase 3 study to assess the efficacy and safety of oral BPS-314d-MR added-on to treprostinil, inhaled (Tyvaso®) in subjects with pulmonary arterial hypertension
PI: William Harvey, MD

A Phase III, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Event Driven Study to Compare the Time to First Clinical Worsening in Subjects with Pulmonary Arterial Hypertension Receiving UT-15C in Combination with a PDE5-I or ERA Compared with a PDE5-I or ERA Alone
PI: William Harvey, MD

An Open-Label Extension Study of UT-15C in Subjects with Pulmonary Arterial Hypertension - A Long-Term Follow-Up to Protocol TDE-PH-310
PI: William Harvey, MD